“I’ve changed my perspective on this drug-substance/drug-product, end-to-end, ‘one-stop-shop’ services trend,” says Rick Panicucci, QED Therapeutics (a BridgeBio Pharma company). Even more, he's an idea of how to change CDMO consolidation dynamics to serve smaller drug sponsors.
- What To Expect From A Remote Inspection -- & How To Navigate It
- The 6 Pillars Of Effectively Managing Up In Clinical Development
- CDMOs Won’t Respect What You Don’t Inspect
- Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation
- The 8-Step Checklist To Write Effective Investigation Reports
- Rare Diseases: How To Leverage Social Media For Patient Analysis
- Serendipity And CDMO Catapult COVID-19 Candidate
The 6 Pillars Of Effectively Managing Up In Clinical Development
Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.
Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation
A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.
The 8-Step Checklist To Write Effective Investigation Reports
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
Rare Diseases: How To Leverage Social Media For Patient Analysis
Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
Medtech Innovation: 3 Strategies For Leveraging Agile Methodologies
While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.
eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?
When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?
Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs
Cell and gene therapy (CGT) production is costly, complex, and high-risk; in part, because most supply chain and manufacturing processes involve multiple stakeholders and facilities. In the first article of this series we discussed how CGT adoption and success hinges on early planning to scale manufacturing and supply. This article describes strategies to enable a patient-centric digital ecosystem and capabilities to support CGTs before, during, and after the order life cycle.
PHARMA OUTSOURCING WHITE PAPERS
How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success
In the realm of Sterile Injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships have a huge influence on project success. Explore how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.
Continuous Flow Manufacturing Of Pharmaceutical Ingredients
Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.
Analyzing Product Formulation Using Raman Microscopy
Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.
Process Characterization: Ready For The FDA?
Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.
Considerations For Improving Outcomes In Biopharmaceutical Process Development
In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.
NMR And Mass Spectrometry In Pharmaceutical Development
Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
OUTSOURCED PHARMA CONTENT COLLECTIONS
In this collection of recent editorials, Outsourced Pharma Chief Editor Louis Garguilo wades into the noisy intersection of national and international politics, and our pharmaceutical industry, from the perspective of our main focus on drug development and manufacturing outsourcing.More Content Collections
PRODUCTS & SERVICES
SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.